Two-way SMS program to spot and prevent wasting in HIV-exposed young children in Kenya
A Mixed Methods Randomized Controlled Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
This study will test whether a two-way text-message program that teaches feeding and helps caregivers monitor nutrition can prevent wasting in HIV-exposed children aged 6–24 months in Kenya.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Homa Bay and 1 other locations) |
| Trial ID | NCT06842732 on ClinicalTrials.gov |
What this trial studies
This is an individually randomized, unblinded trial comparing a maternally administered malnutrition monitoring system with infant and young child feeding (MAMMS IYCF) delivered by two-way SMS to standard of care at clinics in Homa Bay and Migori counties. The trial will enroll about 600 caregiver-child pairs (children 6–24 months, HIV-exposed or living with HIV) who are not moderately or severely wasted at enrollment and who have access to a Safaricom phone. Study staff will collect baseline socioeconomic and medical histories, perform repeated anthropometry (length, weight, MUAC) on children and caregivers, and administer questionnaires about feeding knowledge and care-seeking; no biological samples are collected. Primary outcomes include incidence of malnutrition and related events (time to recovery, hospitalizations, severe malnutrition, and death), with secondary analyses of cost-effectiveness and changes in feeding behavior and trust in the health system.
Who should consider this trial
Good fit: Ideal candidates are HIV-exposed or HIV-positive children aged 6 to 24 months with MUAC ≥ 12.5 cm whose caregivers can consent, have access to a Safaricom phone (and can read or have help reading), and plan to remain in the clinic catchment area for at least six months.
Not a fit: Children already moderate or severely wasted at screening, caregivers without phone access or literacy support, or families who will not stay in the area are unlikely to benefit from this intervention as enrolled participants.
Why it matters
Potential benefit: If successful, the SMS-supported caregiver monitoring could help detect early wasting at home and reduce the number of children who develop severe malnutrition or require hospitalization.
How similar studies have performed: Previous two-way SMS and caregiver-led monitoring interventions have shown promise for improving follow-up and feeding practices in low-resource settings, but evidence specifically showing prevention of wasting in HIV-exposed infants remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (HIV-exposed caregiver-child pairs): * Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment * Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals * The child's caregiver is willing and able to provide informed consent * The child's caregiver can read or write or has someone to help them read or write * The child's caregiver is planning to remain in the catchment area with their child for \> 6 months and willing to return to the health facility for 6-month follow up visits * The child's caregiver has access to a Safaricom phone line and provides a mobile phone number Inclusion Criteria (healthcare workers): \- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients Exclusion Criteria: * Children with moderate or severe wasting (MUAC \<12.5cm, weight-for-height z-score \<-2, or nutritional edema) at the time of eligibility screening * Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding * Child is enrolled in another study that the PI judges to compromise the aims of this study * Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training. * Child's caregiver is under the age of 18 years.
Where this trial is running
Homa Bay and 1 other locations
- Homa Bay County Referral Hospital — Homa Bay, Kenya (Recruiting)
- Migori County Referral Hospital — Migori, Kenya (Recruiting)
Study contacts
- Principal investigator: Arianna R Means, PhD — University of Washington
- Study coordinator: Arianna R Means, PhD
- Email: aerubin@uw.edu
- Phone: 206-370-0225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.